Clinical trial · Interventional
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH). The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Precancer | — | UNRESOLVED | — |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Human Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate vaginal inserts | Drug | — | UNRESOLVED |
| Placebo vaginal inserts | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Artesunate vaginal inserts
- description
- Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
- interventionNames
- Drug: Artesunate vaginal inserts
- type
- PLACEBO_COMPARATOR
- label
- Placebo vaginal inserts
- description
- Participants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).
- interventionNames
- Drug: Placebo vaginal inserts
Primary outcomes (1)
- measure
- Clearance of type-specific HPV genotype(s)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria * Age 25 years or older * Known HIV seropositive status * On antiretroviral therapy for \> 90 days prior to enrollment * Weight ≥50 Kg at study entry\* * Positive HPV screening test and within 4-8 weeks of thermal ablation * Ability to provide informed consent * Planning to stay within the study locale during the duration of the study (24 weeks) * Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study Exclusion Criteria * Current pregnancy or breastfeeding status * Current or past history of invasive cervical cancer * History of total hysterectomy * Currently receiving systemic chemotherapy or radiation therapy for another cancer * Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent) * Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin * Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation * Prior chemotherapy within 30 days prior to day 1 of study treatment * Male at birth
References
Publications (1)
- DERIVEDSadana A, Omoto J, Sorgi K, Rahangdale L, Smith JS, Plesa M, Mungo C. Feasibility of Intravaginal Artesunate as an Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial. Cancer Control. 2025 Jan-Dec;32:10732748251374418. doi: 10.1177/10732748251374418. Epub 2025 Sep 4. PMID 40907021